Polidocanol
Asclera, Varithena (polidocanol) is a small molecule pharmaceutical. Polidocanol was first approved as Asclera on 2010-03-30. It is used to treat varicose veins in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Asclera, Varithena (discontinued: Varithena)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Polidocanol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ASCLERA | Chemische Fabrik Kreussler | N-021201 RX | 2010-03-30 | 2 products, RLD, RS |
| VARITHENA | Provensis | N-205098 RX | 2013-11-25 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| varicose veins | HP_0002619 | D014648 | I83.90 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Varicose veins | D014648 | HP_0002619 | I83.90 | 1 | 3 | 5 | 7 | 10 | 25 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | 5 | 3 | 1 | 2 | 8 |
| Venous insufficiency | D014689 | — | — | — | — | 1 | 1 | 3 | 5 |
| Varicose ulcer | D014647 | — | — | — | — | — | 1 | 2 | 3 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | 1 | 2 | 3 |
| Cysts | D003560 | — | — | — | — | — | 2 | 1 | 3 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | 1 | 1 | 2 |
| Leg ulcer | D007871 | — | — | — | — | — | 1 | 1 | 2 |
| Telangiectasis | D013684 | — | — | — | — | — | 1 | 1 | 2 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 1 | — | 2 | 3 |
| Fibrosis | D005355 | — | — | — | 1 | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | 1 | — | — | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | 1 | 1 | — | — | 1 |
| Hemostatic disorders | D020141 | — | — | — | 1 | 1 | — | — | 1 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Cutaneous malignant melanoma | D000096142 | — | — | — | 1 | — | — | — | 1 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | 1 | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 1 | 1 | — | — | — | 1 |
| Snoring | D012913 | — | R06.83 | 1 | 1 | — | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 3 | — | — | — | — | 3 |
| Neurofibromatoses | D017253 | — | Q85.00 | 3 | — | — | — | — | 3 |
| Neurofibroma | D009455 | EFO_0000622 | — | 3 | — | — | — | — | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 7 | 7 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 2 | 2 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | — | — | 2 | 2 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | — | — | — | — | 2 | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | HP_0001907 | — | — | — | — | — | 1 | 1 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | — | — | 1 | 1 |
| Vaginal diseases | D014623 | — | — | — | — | — | — | 1 | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | — | — | 1 | 1 |
| Hand dermatoses | D006229 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Polidocanol |
| INN | lauromacrogol 400 |
| Description | Polidocanol is a hydroxypolyether that is nonaethylene glycol in which one of the terminal hydroxy functions is substituted by a lauryl (dodecyl) group. It has a role as a nonionic surfactant, a hepatotoxic agent and a sclerotherapy agent. It is functionally related to a nonaethylene glycol. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO |
Identifiers
| PDB | — |
| CAS-ID | 3055-99-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1231723 |
| ChEBI ID | 46859 |
| PubChem CID | 656641 |
| DrugBank | — |
| UNII ID | 0AWH8BFG9A (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,080 adverse events reported
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